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Volume 2 - Notice to Applicants. Volume 2A deals with procedures for marketing authorisation. Volume 2B deals with the presentation and content of the application dossier. Volume 2C deals with Guidelines. Volume 3 - Guidelines. Concerning Medicinal Products for human use in clinical trials (investigational medicinal products).
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
If the marketing authorisation is not renewed in due time as requested by the local legislation, in order to maintain the pharmaceutical product on a market, one can apply for re-authorisation (re-registration). In such situations, the applicant may be requested to submit the whole items necessary for a full application.
The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
With respect to (a) above, the question of how to determine whether a "product" is protected by a patent is the subject of ongoing controversy. Cases such as C-322/10 and C-422/10 have indicated that the "product" needs to be "specified [or identified] in the wording of the claims". However, the precise meaning of this test is yet to be clarified.
Get answers to your AOL Mail, login, Desktop Gold, AOL app, password and subscription questions. Find the support options to contact customer care by email, chat, or phone number.
An Ohio man allegedly slammed a 15-month-old girl on the floor after she wouldn’t stop crying, fracturing her skull. Two weeks later, she died of her injuries.
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